The pharmacopoeia is a collection of standards and guidelines issued by national or international regulatory authorities, such as the European Pharmacopoeia Commission or the United States Pharmacopeia (USP). It provides detailed specifications for the quality of pharmaceuticals, active ingredients, excipients, and other materials used in drug manufacturing.
The pharmacopoeia serves as a reference for the pharmaceutical industry, pharmacists, physicians, regulatory agencies, and other healthcare professionals to ensure that medicines and related products meet required quality standards and are both safe and effective. It defines standards for identity, purity, potency, quality, and safety, ensuring compliance with national and international regulations.
Compliance with pharmacopoeial standards is mandatory for pharmaceutical manufacturers to guarantee the quality, efficacy, and safety of their products and obtain regulatory approval. Additionally, it is a key reference for regulatory authorities worldwide when testing and evaluating pharmaceuticals.